SILS™ Port Laparoscopic Cholecystectomy Post Market Study

Medtronic

Status: Completed

Conditions: Gallbladder Disease

Treatments: Procedure: Four Port Laparoscopic Cholecystectomy; Procedure: SILS™ port laparoscopic cholecystectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832767

AS08012

Details and patient eligibility

About

The objectives of this trial are:

1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 18 and 85 years old.
• Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF < 30%.
• Body Mass Index (BMI) < 45 kg/m2.

Exclusion criteria

• Any female patient, who is pregnant, suspected pregnant, or nursing.
• Any patient with acute calculus or acalculous cholecystitis.
• Any patient who has had an upper midline or right sub costal incision.
• Any patient with pre-operative indication for a cholangiogram.
• Any patient with ASA > 3 with normal liver function.
• Any patient who is undergoing Peritoneal Dialysis (PD).
• Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

SILS Port

Active Comparator group

Description:

SILS™ Port Laparoscopic Cholecystectomy

Treatment:

Procedure: SILS™ port laparoscopic cholecystectomy

Four Port

Active Comparator group

Description:

Four Port Laparoscopic Cholecystectomy

Treatment:

Procedure: Four Port Laparoscopic Cholecystectomy